NCT01073423

Brief Summary

The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

February 17, 2010

Last Update Submit

June 22, 2010

Conditions

Insomnia

Keywords

HIVsleepinsomniayogamusic

Outcome Measures

Primary Outcomes (1)

  • self-reported sleep disturbance

    8 weeks

Secondary Outcomes (2)

  • actigraphic estimates of sleep quality and quantity

    8 weeks

  • self-reported well-being

    8 weeks

Study Arms (2)

Yoga

EXPERIMENTAL
Behavioral: Yoga

Music Therapy

ACTIVE COMPARATOR
Behavioral: Music Therapy

Interventions

Music TherapyBEHAVIORAL

1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.

Music Therapy
YogaBEHAVIORAL

1-hour yoga sessions administered in group format 3 times per week for 8 weeks

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • HIV seropositive
  • current sleep disturbance
  • able to speak, read, and write in English
  • a phone number to maintain contact with research team
  • willing to provide copy of most recent CD4 and viral load values
  • willing to wear actigraph for 1 week per month for 3 months
  • willing to participate in group intervention sessions 3 times per week for 8 weeks

You may not qualify if:

  • pregnancy
  • psychiatric diagnosis, such as schizophrenia, dementia, bipolar disorder (depression not excluded)
  • sleep disorder diagnosis, such as apnea or narcolepsy (insomnia not excluded)
  • current yoga practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Music TherapyYoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Kathryn A. Lee, RN, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 23, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 23, 2010

Record last verified: 2010-06